Recruiting

Cannabis

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06863740

Conditions

Restless Leg Syndrome (RLS)

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Interventions

Cannabis oil

Cannabis placebo

Study Details

Brief summary:

Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.

Conditions

Restless Leg Syndrome (RLS)

Study ID

NCT06863740

Start date

Jul 25, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥25 years of age
  • diagnosis of RLS based on the International RLS Study Group criteria
  • refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
  • onset of RLS at least 6 months before screening

Exclusion Criteria:

  • sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of >15)
  • cannabis use within 4 weeks of study enrollment
  • known allergy to cannabis, cannabinoids or palm/coconut oil
  • Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation)
  • Active substance abuse
  • Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension
  • Serious liver disease
  • History of schizophrenia or any other psychotic disorder

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cannabis Arm

5:1 CBD:THC oral cannabis

placebo comparator: Placebo Arm

Oral placebo

Interventions

Cannabis oil

5:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil.

Cannabis placebo

Placebo oil

Primary outcome measure

  • Incidence of Adverse Events and Serious Adverse Events [ Time Frame: 8 weeks ]
  • Rate of Study Completion [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Mark Boulos, MD

416-480-4473mark.boulos@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Mark Boulos, MD

416-480-4473mark.boulos@sunnybrook.ca

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Hance Clarke, MD

416-340-5164Hance.Clarke@uhn.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-28.